New drug research and development “near death” is staged again!
On December 28, Hong Kong listed companies opened pharmaceutical-b, which fell by more than 80%. As of the close, Kaifa pharmaceutical-b reported HK $13.38/share, down about 70.4%. It is worth mentioning that the share price of Kaifa pharmaceutical continued to rise, from HK $10.46 / share at the beginning of the year to HK $89 / share, a high of nearly 750%.
The stock price of Kaifa pharmaceutical fell sharply, and the direct trigger was a less than expected clinical phase III report. On December 27, 2021, Kaifa pharmaceutical announced the progress of phase III clinical trial (nct04870606) of prochloramide in the treatment of mild and moderate non hospitalized covid-19 patients. According to the interim analysis data of 348 patients with covid-19, it did not reach statistical significance due to the small number of events.
In response to this, Tong Youzhi, founder, chairman and CEO of pioneer pharmaceutical, told the Securities Daily that unlike MSD and Pfizer for specific high-risk groups, the clinical trial of prochloramide developed by the company is aimed at the whole population. “The high-risk group was selected as the placebo control group, and the proportion of people entering the hospital was relatively high. In the whole population clinical trial, due to the large-scale vaccination of covid-19 vaccine in the United States, the number of severe patients in the placebo control group decreased and the number of hospitalizations was too small. Therefore, there was no statistically significant probability increase in the value.”
On December 28, at the telephone exchange meeting of covid-19 test of developing pharmaceutical industry, Tong Youzhi said: “the medium-term analysis data is not ideal, resulting in a big problem that the business plan is delayed. This is a very obvious thing. The company will make some new judgments and Analysis on the commercialization of covid-19 oral drugs under research.”
“In the follow-up, we will communicate with the regulatory authorities to recruit high-risk covid-19 patients with only basic diseases and / or no covid-19 vaccination history.” Tong Youzhi told reporters.
Kaifa pharmaceutical will readjust the plan
In the field of oral small molecule drug development, Chinese pharmaceutical enterprises have found that prochloramide shows a positive effect on patients with covid-19. Therefore, based on the original anticancer drugs, the development pharmaceutical industry has officially opened the clinical research of prochloramide in the treatment of covid-19, which has become the focus of market attention.
At present, pioneer pharmaceutical has conducted two phase III global multicenter clinical trials of prochloramide for mild and moderate non hospitalized covid-19 patients and one phase III global multicenter clinical trial for critically hospitalized covid-19 patients in the United States, South America (including Brazil), the European Union and Asia (including China).
In response to the progress of the phase III clinical trial (nct04870606) of prochloramide in the treatment of mild to moderate disease non hospitalized covid-19 patients mentioned above, Kaifa pharmaceutical said that the company plans to adjust the clinical trial scheme and seek the consent of FDA and other regulatory agencies to continue to recruit high-risk covid-19 patients with only basic diseases and / or no history of covid-19 vaccination. Based on the interim analysis results, the safety of prochloramide was good, and no drug-related serious adverse events (SAEs) were reported. By December 23, 2021, the clinical trial had completed the enrollment of all patients according to the original protocol, and more than 95% of the patients were from the United States. The 348 patients enrolled in the interim analysis were all from the United States , and the overall hospitalization rate of covid-19 patients in the United States was very low.
Patient recruitment is an important factor in the poor performance of the interim data of this clinical trial.
Molnupiravir of MSD and paxlovid of Pfizer made specific requirements for enrolled patients during the design of phase III trial.
Among them, molnupiravir phase III trial of MSD is a multicenter, double-blind, randomized controlled trial. The patients required to meet three conditions at the same time: mild to moderate symptoms of covid-19; There is at least one risk factor associated with serious illness (such as obesity, >60 years of age, diabetes, heart disease, etc.). The time from the onset of symptoms was no more than 5 days.
Pfizer’s paxlovid phase III clinical trial requires all enrolled patients to be diagnosed with mild to moderate covid-19 virus infection within 5 days, and at least one basic disease risk that may develop into severe disease. In contrast, the covid-19 patients recruited by pioneer pharmaceutical did not exclude those who had been vaccinated with covid-19, nor did they exclude patients without risk factors.
“The clinical trials carried out by pioneer pharmaceutical in the United States are aimed at the whole population, which means that the population vaccinated with covid-19 vaccine will also enter the control group, thus reducing the probability of admission of patients in the control group. If the scheme is adjusted and statistically significant, it is likely to mean larger-scale recruitment of clinical trial population, which means more cost.” An insider told reporters.
In addition, according to Kaifa pharmaceutical, another phase III global multicenter clinical trial (nct04869228) for non hospitalized covid-19 patients with mild and moderate diseases is planned to recruit 724 patients. The main endpoint of the clinical trial is the percentage of subjects who need oxygen within 28 days. The phase III global multicenter clinical trial (nct05009732) for critically ill hospitalized patients with covid-19 is a randomized, double-blind, placebo-controlled, global multicenter phase III registered study. Male and female (non pregnant) hospitalized adult patients with covid-19 are recruited. The main end point of the clinical trial is the time required for patients to recover, and the key secondary end point is the percentage of mortality.
“We will also communicate with relevant departments to adjust the plan.” Tong Youzhi said that at present, the company’s cash flow is relatively abundant, and the interim data of the clinical trial will not have an impact on the development of the company.
research and development progress of global covid-19 oral pharmaceutical industry
Facing the challenge of covid-19 virus, covid-19 oral therapeutic drugs are expected. Among them, oral small molecule chemical drugs have attracted much market attention due to their advantages of convenient administration and low cost.
On December 22, Pfizer announced that the US FDA had approved its emergency authorization application (EUA) for paxlovid, a new oral antiviral candidate of covid-19, to treat covid-19 infection in non hospitalized adults at high risk of developing into severe diseases.
On November 5, Pfizer announced the latest research results of its oral covid-19 pneumonia candidate paxlovid. The results showed that paxlovid could reduce the hospitalization rate of non hospitalized patients with covid-19 pneumonia by 89%. Among them, the hospitalization rate in the treatment group was only 0.8% (3 of 389 patients were hospitalized), and the mortality was 0.
Tong Youzhi, founder, chairman and CEO of pioneer pharmaceutical, once said in an interview with the Securities Daily that from the currently published data, the clinical trial population of covid-19 oral pneumonia drug under research by Pfizer is unvaccinated adults. In terms of the protection rate from mild disease to severe disease, the effect is better than that of monopivir developed and produced by MSD.
In addition to Pfizer, the monopivir developed by MSD has also attracted much attention. MSD took the lead in applying for emergency use authorization, production and supply. MSD China’s official wechat disclosed on November 5 that the UK drug and Health Products Administration approved monopivir for the treatment of adult patients with mild to moderate covid-19 pneumonia who were positive for sars-cov-2, and these patients had at least one severe risk factor.
Facing the huge market demand, covid-19 oral drug market has become a hot track. According to Southwest Securities Co.Ltd(600369) , the global oral covid-19 drug market is expected to be billions to tens of billions of dollars.
In addition to developing the pharmaceutical industry, Shanghai Junshi Biosciences Co.Ltd(688180) and Xiansheng pharmaceutical also accelerated their layout. For example, Shanghai Junshi Biosciences Co.Ltd(688180) has reached a cooperation with Wangshan wangshui biology to jointly undertake the global clinical development and industrialization of oral nucleoside anti covid-19 virus candidate drug vv116. The contract of technology transfer between the Shanghai Pharmaceutical Institute and the pioneer pharmaceutical company has obtained the exclusive right of anti New Coronavirus candidate SIM0417 Series in global development, production and commercialization.
(Securities Daily)
